Evaluation of Treatment of Fractures of the Humerus With a Plate.
NCT ID: NCT00408291
Last Updated: 2024-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2011-12-31
2023-03-31
Brief Summary
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Detailed Description
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1. Pain
2. Activities of Daily Living (ADL)
3. Range of Motion (ROM)
4. Muscle strength
We shall measure the following radiologic parameters:
1. Healing (migration) of tuberculum majus and minus measured with use of MB-RSA
2. Plate migration with use of MB-RSA
3. Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
4. Correlation between bone density and prosthesis migration (and tuberculum migration)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Winsta PH osteosynthesis device (Fischer Medical)for treatment of humeral fracture
Winsta PH osteosynthesis device
The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.
Interventions
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Winsta PH osteosynthesis device
The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged 50 years or older and fit
3. Informed, written consent
4. A functioning shoulder preoperatively -
Exclusion Criteria
2. Patients aged 85 or older
3. Patients with rheumatoid arthritis
4. Patients who previously had undergone shoulder plastic or other major shoulder surgery
5. Patients unable to avoid NSAID after surgery
6. Patients requiring regular systemic steroid treatment
7. Female patients taking hormone substitution
8. Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings)
9. Patients with metabolic bone disease -
50 Years
85 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Kjeld Soballe, Professor
Role: STUDY_DIRECTOR
Orthopaedic Department, Aarhus University Hospital
Locations
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Orthopaedic Department K, Silkeborg Hospital
Silkeborg, , Denmark
Countries
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References
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Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Other Identifiers
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20060166
Identifier Type: -
Identifier Source: org_study_id
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